EU → North America Device Access

Trulife Ltd

GB-MF-000015741 · United Kingdom · Sheffield

Trulife Ltd is registered in the European database on medical devices as a manufacturer, with 173 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa173

Authorised representative in the Union: MDSS GmbH.

Devices declared under this manufacturer

Showing 12 of 173 declared devices.

Catalogue references include FH270L03, FH450R04, FH500L01, RM512300, RM516200, RM520300.

European nomenclature codes declared: Y06120602, Y120606, Y12030601, Y120603, Y120399, Y120315.

United States market access

FDA establishment registerRegistered with FDA
Matched entryTRULIFE LIMITED (CA) · FDA 9615374
Devices in EUDAMED173
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN173
Found in the U.S. device database48
Share27.7 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: United States only. Trulife Ltd is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

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